NCT01574222

Brief Summary

The purpose of this study is to determine the dose that the vaccine can be given safely to patients when injected directly into the lung tumor, without any serious side effects.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

5.4 years

First QC Date

March 28, 2012

Last Update Submit

January 16, 2018

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Keywords

Stages IIIB, IV, and recurrent NSCLCCarcinoma, Non-small cell lungLung NeoplasmsCarcinoma, BronchogenicThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung Diseases

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD)

    Toxicity as measured by NCI Common Toxicity Criteria

    28 Days

Secondary Outcomes (1)

  • Disease status at days 28 and 56 days

    28 and 56 Days

Study Arms (1)

Arm 1

EXPERIMENTAL

Eligible patients will be assigned to a cohort and will receive intratumoral injections of Ad-CCL21-DC in conjunction with tumor sampling

Biological: autologous dendritic cell adenovirus CCL21 vaccine

Interventions

autologous dendritic cell adenovirus CCL21 vaccineBIOLOGICAL

Eligible patients will be assigned to a cohort and will receive intratumoral injections of Ad-CCL21-DC in conjunction with tumor sampling.

Also known as: 10-000039, UCLA-NCI 7888, 03-06-008
Arm 1

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Screening, physical exams, blood draws, CT scans, and follow-up will be performed at VA Greater Los Angeles. All interventional procedures including leukapheresis, CT guided/bronchoscopic biopsies and vaccine injections will be performed at University of California Los Angeles (UCLA).
  • Adults over the age of 21 capable of giving informed consent
  • Pathologically confirmed non-small cell lung cancer (NSCLC)
  • Stage IIIB, IV or recurrent disease
  • Progressive disease despite one or more prior chemotherapy regimens as standard of care OR patient refusal of standard chemotherapy
  • Measurable metastatic disease by RECIST guidelines
  • Patients with a major endobronchial lesion in the segmental, lobar, or mainstem bronchus with complete obstruction of the airway may be eligible for bronchoscopic injection provided there is no evidence of respiratory failure (defined as SaO2 at least 90% on room air, PCO2 less than, or equal to 45 mm Hg, or FEV1 greater than 1.0L)
  • Patients with an endobronchial lesion in the segmental bronchus with variable stenosis (not completely obstructed) and not amenable to standard palliative airway treatments (i.e., laser and stenting) may be eligible for bronchoscopic injection if there is no indication of respiratory failure as defined above
  • Patient with bullous disease may undergo CT-guided transthoracic injection provided the targeted tumor has an intended needle path without crossing bullae
  • ECOG performance status 0-2
  • BUN less than or equal to 40 OR serum creatinine less than 2 Serum total bilirubin less than or equal to 1.5 OR serum transaminases less than or equal to 2.5 times upper limit of normal (ULN)
  • Negative pregnancy test (if applicable)
  • Fertile patients must use effective contraception
  • More than 14 days since prior acute therapy for viral, bacterial, or fungal infections
  • More than 30 days since prior and no concurrent corticosteroids
  • +2 more criteria

You may not qualify if:

  • Active CNS metastases (i.e., progression of CNS disease during the past 30 days without intervention)
  • Evidence of coagulopathy, defined as PT and/or PTT more than 1.5 times ULN or platelets more than or equal to 100,000/mm3.
  • Evidence of leukoplakia, defined as absolute neutrophil count more than or equal to 1,500/mm3
  • Evidence of respiratory failure (defined as SaO2 less than 90% on room air, PCO2 more than 45 mm Hg, or FEV1 less than 1.0 L
  • NYHA class III-IV within the past year
  • Myocardial infarction within the past year
  • Comorbid disease or medical condition that would impair the ability of the patient to receive or comply with the study protocol
  • Acute viral, bacterial or fungal infection that requires specific therapy
  • HIV positive
  • Hypersensitivity to any reagents used in the study
  • Signs or sensitivity of acute adenoviral infection (i.e., conjunctivitis or documented adenoviral upper respiratory infection)
  • Pregnant or nursing
  • Prior organ allograft

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

Related Publications (1)

  • Lee JM, Lee MH, Garon E, Goldman JW, Salehi-Rad R, Baratelli FE, Schaue D, Wang G, Rosen F, Yanagawa J, Walser TC, Lin Y, Park SJ, Adams S, Marincola FM, Tumeh PC, Abtin F, Suh R, Reckamp KL, Lee G, Wallace WD, Lee S, Zeng G, Elashoff DA, Sharma S, Dubinett SM. Phase I Trial of Intratumoral Injection of CCL21 Gene-Modified Dendritic Cells in Lung Cancer Elicits Tumor-Specific Immune Responses and CD8+ T-cell Infiltration. Clin Cancer Res. 2017 Aug 15;23(16):4556-4568. doi: 10.1158/1078-0432.CCR-16-2821. Epub 2017 May 3.

    PMID: 28468947DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung NeoplasmsCarcinoma, BronchogenicThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung Diseases

Condition Hierarchy (Ancestors)

Bronchial NeoplasmsRespiratory Tract NeoplasmsRespiratory Tract Diseases

Study Officials

  • Steven Dubinett, MD

    VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Masking Details
No masking
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2012

First Posted

April 10, 2012

Study Start

October 1, 2011

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)